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A Study of Abemaciclib and Radiation Therapy in People With Metastatic Breast Cancer

NCT06678269 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2026-02-12

No results posted yet for this study

Summary

The purpose of this study is to test different doses of abemaciclib to find the best dose in participants while receiving hormone therapy and radiation therapy.

Conditions

Interventions

DRUG

Abemaciclib

The dose escalation portion of the study, a 3+3 design will be used. Once the MTD of Abemaciclib is reached, the phase Ib expansion portion will enroll up to 10 additional patients also requiring palliation to bone metastases

RADIATION

Radiation Therapy

27Gy in 3 daily fractions or 30Gy in 5 daily fractions completed entirely within 28 days of simulation via stereotactic body radiotherapy (SBRT).

Sponsors & Collaborators

Principal Investigators

  • Lior Braunstein, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-15
Primary Completion
2028-11-30
Completion
2028-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06678269 on ClinicalTrials.gov